1. Field of the Invention
The present invention relates to self-programmable wireless medical devices. In particular, the present invention relates to a self-programmable wireless medical device with a built-in intelligence to learn and to self-adapt its monitoring capabilities to an individual patient's needs. Furthermore, the present invention is capable of uploading various software applications from outside computing devices, enabling it to adapt its monitoring capabilities to a wide range of medical applications. Among these medical monitoring applications are included a self-programmable wireless electrocardiogram (ECG) device as well as a self-programmable wireless electroencephalogram (EEG) device and a self-programmable wireless electromyogram (EMG). The ECG monitoring system and its novel innovations are described here in details.
The present invention further relates to a self-programmable wireless electrocardiogram (ECG) monitoring system. More specifically, the present invention relates to an ECG monitoring system with a built-in intelligence to learn and self-adapt its monitoring capabilities to an individual patient's needs. The ECG device continuously records and monitors the patient's cardiovascular activity to identify and extract various parameters that are then utilized to further optimize the built-in arrhythmia detection algorithms. The optimized algorithms are then uploaded for future monitoring purposes. In the event that an abnormal event is detected, the recorded cardiovascular data leading to and prior to the abnormal event is then scrutinized to further optimize the detection algorithms being used on this patient. Optimized detection algorithms and parameters are then uploaded and activated for all future monitoring of the patient. The ECG device is further capable of performing image recognition and overlay techniques using historical recordings to further optimize its monitoring capabilities and identify “trends” in patient's heart activity. In one configuration, the ECG unit can communicate the recorded cardiovascular data wirelessly to outside computing devices for further analysis and monitoring purposes. The ECG monitoring device can be mounted on disposable media such as a patch for ease of use and added comfort. The ECG device is capable of uploading software applications and detection algorithms enabling it to further adapt itself to new applications including but not limited to electroencephalogram (EEG) and electromyogram (EMG).
2. Description of Prior Art
ECG systems are used for monitoring activity of a patient's heart. A number of electrodes are positioned on the patient. Wires are connected from the electrodes to an ECG monitor. The ECG monitor processes the signals and outputs ECG data, in form of traces representing activity of the heart by measuring electrical signals at different positions on the patient.
Several classes of ECG monitoring devices are presently available in the market. Each of these devices exhibits major issues and limitations that the current invention resolves.
The most common class of ECG monitoring devices are stand-alone ECG monitoring systems which are generally used to monitor and record patient's cardiovascular activity within a hospital or clinic environment and display or print the resulting waveforms for a doctor's viewing. One fundamental problem is that the wires of these devices inhibit movement by and around the patient. Because the patient is wired to the stationary ECG device, doctors must work around the wires to gain access to the patient.
Additionally, there are classes of ECG devices that are portable monitoring devices that do not connect the patient to an external stand-alone device. However, these, like their stand-alone counterparts have numerous shortcomings. Many of the prior art portable ECG monitoring devices are intended to be recording devices only. These devices record cardiovascular data over long periods of time for later viewing and analysis. Additionally, these devices are incapable of performing any type of analysis of the patient's cardiovascular condition. These devices are not interactive and are not remotely self-programmable. An example of such devices is the ubiquitous Holter ambulatory ECG monitor. This device is worn typically around the neck of the patient and is about the size of a tape recorder. From the bottom of the Holter monitor are several wires, generally five, that attach to electrodes that are placed about the patient's torso by sticky pads. Holter monitors continuously record a patient's ECG waveform over an extended period of time such as a 24-hour period or several weeks. These devices often contain a large storage memory for recording the patient heart waves over these long time periods. The patient carries the complete monitor and recorder. The Holter ECG devices record the cardiovascular data only; they cannot scrutinize the data, they merely save it for the primary care physician to review later. The data recorded by a Holter monitor is known and can be analyzed only after the recording period is over; therefore, if the patient experiences an abnormality, the Holter device is incapable of performing an immediate analysis or of assisting the patient by interactively communicating with a doctor. Additionally, Holter monitors lack the processing power and the necessary software algorithms to immediately analyze the ECG data.
Another class of ECG devices are portable extended-wear ECG monitoring devices, some of which store the recorded heart information and, in some cases, transmit that information wirelessly, to a local base station which relays the ECG data by phone to a diagnostic center where it can be promptly scrutinized for arrhythmias. However, this method constrains the normal daily activities of the patient, as the patient must continually stay within range of the local base station. Additionally, these devices don't perform any analysis nor are they self-programmable or adaptable to the patient's unique monitoring needs. Of those devices that are capable of some sort of analysis, such analysis is very limited and fixed. They cannot do any in-depth analysis and because they have fixed programs, they cannot upload or download software and algorithms that customize the detection, analysis and reporting for the patient's unique and individual needs.
Furthermore, among the portable extended-wear ECG monitoring devices, there are those that take the form-factor of a patch with adhesive contact to be placed directly on the patient's chest. These include both the disposable single-use ECG patches as well as the reusable type. Such patches are utilized by Holter monitors to simply record cardiovascular data over a period of time for future analysis by the physician. This group of portable ECG devices provides a higher level of comfort to the patient being monitored over a long period of time; however they lack the ability to transmit the recorded information wirelessly to outside devices. Once the recording period has elapsed, the device's contents are then analyzed by the physician.
Another class of ECG monitoring devices are portable extended-wear ECG monitoring devices capable of recording cardiovascular activity, transmitting that information wirelessly to an outside computing device, wherein said computing device makes this information available for a physician's review and analysis on the recorded cardiovascular data. However due to their limited processing power and their fixed built-in arrhythmia detection algorithms contained in their internal storage area, such patches are also very limited in their scope and accuracy in detection of abnormal heart activity.
Another class of ECG monitoring devices are portable extended-wear ECG monitoring devices that are equipped with the capability of analyzing and scrutinizing the patient's cardiovascular data for arrhythmia and other abnormal heart conditions.
Another class of ECG monitoring devices is wireless portable extended-wear ECG monitoring devices that work interactively with outside computing devices in order to optimize their detection algorithms. Such devices communicate to the outside commuting device the recorded patient cardiovascular information leading to each abnormal event via telemetry. The recorded information is then scrutinized by the outside computing device in order to generate more effective detection algorithms to be uploaded back into the portable ECG monitoring device. What is lacking in such devices is the ability to self-program and improve built-in detection algorithms without the aid of outside computing devices.
Most of the above classes of ECG monitoring devices can have the form-factor of a patch.
What is needed is an ECG device that has the capability to record the patient cardiovascular activity over an extended time period, such as a 24-hour period or longer, in conjunction with the ability to transmit the recorded data automatically or on-demand to an outside wireless computing device. Furthermore, there is a significant need for a wireless ECG monitoring device that is capable of analyzing and scrutinizing the patient's cardiovascular data for arrhythmia and other abnormal heart conditions. Also, in the event that abnormal activity or activities are detected, there is a significant need for an ECG monitor that can optimize its built-in detection algorithms to each patient's unique requirements by analyzing the recorded heart data leading to each abnormal event and extracting essential ECG parameters, without requiring any human assistance or interactions with outside computing devices. Additionally, there is a vital need for an ECG device that can process current as well as historical heart recordings to help identify “trends” in the patient's cardiovascular health. Furthermore, there is a need for an ECG device capable of uploading new application software both via local connection, as well as via telemetry, to help improve its performance and help expand its detection capabilities in other fields including but not limited to electroencephalogram (EEG), electromyogram (EMG), blood pressure, oxygen levels and the like. The present invention provides all of the above capabilities and corrects the deficiencies of the prior art.